An interventional study of VeinOPlus in Post Thrombotic Syndrome, Deep Vein Thrombosis and Venous Stasis Syndrome, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-29.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
The investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (QOL) benefits.
The purpose of this study is to determine the optimal electrical stimulation intensity level at which subjects using the portable electrical muscle stimulator (VeinoPlus) have the largest benefit for relief of post thrombotic symptoms. To determine if the subjects reported benefit from the device and willingness to continue using the device.
Subjects will be pre-screened on the phone for eligibility, and an initial appointment will be set. The subject will be given a device and complete a quality of life survey. The subject will also be assessed on the Villalta scale. After two months, the subjects will return for the final visit where the Villalta scale and quality of life survey will be reassessed, and the device taken back.
73 studies on the registry are indexed under Postthrombotic Syndrome; 21 are open to participants now.
This study's enrollment of 12 is below the median of 95 across 46 interventional studies indexed under Postthrombotic Syndrome.
Browse Postthrombotic Syndrome studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
Device: VeinOPlus
The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months.
Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms
The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (\<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.
Time frame: Visit 2 (Week 8)
Number of Study Participants Classified as a "Clinical Success"
Clinical success was defined by the patient reporting benefit (moderate improvement of symptoms after having used the device) and an interest and willingness to continue using the device. For this study both legs were measured, but only the more severely affected leg (as determined by higher Villalta score) was used to determine clinical success. Patients were asked the following question: "How much have symptoms improved?" with the following possible responses: "a little;" "moderate;" "a good deal;" "a great deal;" or "a very great deal."
Time frame: Visit 2 (Week 8)
Number of Study Participants With Improvements in PTS Severity (Villalta Score)
The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness and was used to characterize PTS severity. Points are given for 11 descriptors according to severity from 0 (not present) to 3 (severe) with overall scores ranging from 0 to 33. Higher scores represent more severe disease. A score of ≥ 5 indicated mild PTS; 10-14 moderate PTS; and a score of ≥15, or the presence of a venous ulcer, indicated severe PTS. Those participants with a Villalta score decrease at Visit 2 in comparison to Visit 1 were counted as having improved.
Time frame: Visit 2 (Week 8)
Number of Study Participants With Improvements in QOL (VEINES-QOL Score)
The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-QOL score increase at Visit 2 in comparison to Visit 1 were counted as having improved.
Time frame: Vist 2 (Week 8)
Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)
The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-Sym score increase at Visit 2 in comparison to Visit 1 were counted as having improved.
Time frame: Vist 2 (Week 8)
| Milestone | VeinoPlus |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (\<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.
| mirco coulombs (0 to 50) | VeinoPlus |
|---|---|
| Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms | 32 (20 to 40) |
Clinical success was defined by the patient reporting benefit (moderate improvement of symptoms after having used the device) and an interest and willingness to continue using the device. For this study both legs were measured, but only the more severely affected leg (as determined by higher Villalta score) was used to determine clinical success. Patients were asked the following question: "How much have symptoms improved?" with the following possible responses: "a little;" "moderate;" "a good deal;" "a great deal;" or "a very great deal."
| Participants | VeinoPlus |
|---|---|
| Number of Study Participants Classified as a "Clinical Success" | 7 |
The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness and was used to characterize PTS severity. Points are given for 11 descriptors according to severity from 0 (not present) to 3 (severe) with overall scores ranging from 0 to 33. Higher scores represent more severe disease. A score of ≥ 5 indicated mild PTS; 10-14 moderate PTS; and a score of ≥15, or the presence of a venous ulcer, indicated severe PTS. Those participants with a Villalta score decrease at Visit 2 in comparison to Visit 1 were counted as having improved.
| Participants | VeinoPlus |
|---|---|
| Number of Study Participants With Improvements in PTS Severity (Villalta Score) | 8 |
The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-QOL score increase at Visit 2 in comparison to Visit 1 were counted as having improved.
| Participants | VeinoPlus |
|---|---|
| Number of Study Participants With Improvements in QOL (VEINES-QOL Score) | 10 |
The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-Sym score increase at Visit 2 in comparison to Visit 1 were counted as having improved.
| Participants | VeinoPlus |
|---|---|
| Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score) | 9 |
Collected over Adverse event data was collected for the entire duration of study subject participation which was 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VeinoPlus Experimental Arm | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | VeinoPlus Experimental Arm |
|---|---|
| "pinhole leak" near subject's left ankleSkin and subcutaneous tissue disorders | 1/12 |
| Age, Continuous(years) | VeinoPlus |
|---|---|
| Median | 54 (21 to 64) |
| Sex: Female, Male(Participants) | VeinoPlus |
|---|---|
| Female | 10 |
| Male | 2 |
| Leg Calf Circumference(centimeters (cm)) | VeinoPlus |
|---|---|
| Median | 41 (33 to 51) |
| Villalta Scale(units on a scale) | VeinoPlus |
|---|---|
| Median | 13 (6 to 22) |
| VEINES-Quality of Life (QOL)(units on a scale) | VeinoPlus |
|---|---|
| Median | 48.30 (31.11 to 57.46) |
| VEINES-Sym(units on a scale) | VeinoPlus |
|---|---|
| Median | 46.93 (36.67 to 58.41) |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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